Cohort study shows U-500 insulin maintains diabetes control in adults using automated insulin delivery systems, suggesting safety and effectiveness.
Introduction and Objective: People with diabetes and severe insulin resistance require U-500 insulin. Its use in AIDs remains unvalidated with evidence limited to two case reports Methods: We reviewed charts of all adults with diabetes using U-500 insulin in AID (2016-2025). We compared CGM and pump data at baseline (pre-AID), 3 months, and last follow-up. Results: We included four adults using U-500 insulin via AID. Figures 1A to 1D show CGM and total daily dose (TDD) trends. U-500 insulin improved or maintained control without increase in hypoglycemia (Fig 1A and 1D). Among individuals with available data, mean A1c fell from 6.57% to 6.40% (3 months) and to 6.35% (last) (Fig 1B). TDD stayed stable or decreased (Fig 1C). Providers used simplified basal profiles, longer active insulin time, and conservative sensitivity factor or insulin to carb ratios. No DKA or severe hypoglycemia occurred. Conclusion: This cohort study is the largest experience of U-500 insulin use in AID systems in the literature. Our data suggests that U-500 insulin can be used safely in AID systems. Disclosure D. Lee: None. A. Pham: None. M. Abreu: Other - Wife works as a diabetes educator for Sequel meditech; Current; Sequel meditech.
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Lee et al. (2026) studied this question.
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